Compliance & documentation
Compliance
For qualified B2B evaluation, not medical, legal or regulatory advice.
PAMITEX GROUP Kft. is listed in EUDAMED as an Importer economic operator with SRN HU-IM-000038885.
The devices in this catalogue are CE-marked Class IIb medical devices under Regulation (EU) 2017/745 (MDR), certified under notified body 0123: condoms and non-sterile lubricant gel. PAMITEX GROUP Kft. acts as an EU importer and reviews qualified B2B projects individually.
Compliance references from available documentation
Based on available documentation.
Importer (economic operator)
Based on documents PAMITEX GROUP Kft.
EUDAMED SRN: HU-IM-000038885
Hungary
CE marking & quality system
Based on documentsCE-marked Class IIb medical device under Regulation (EU) 2017/745, CE 0123, manufactured under a certified quality management system. Certificate number and manufacturer details may be reviewed with qualified B2B partners upon request.
MDR certificate
Based on documents EU Quality Management System Certificate MDR
Regulation (EU) 2017/745, Annex IX, Chapters I and III
Certificate details and validity status may be reviewed with qualified B2B partners upon request.
Device classification
Condoms: Class IIb, U110101 - CONDOMS
Lubricant gel: Class IIb, M9002 - PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES
Other related products, where applicable, are subject to their own classification and documentation.
Applied standards (selection)
- EN ISO 4074:2015
- EN ISO 14971:2019
- EN ISO 13485:2016
- ISO 9001:2015
Applied standards shown are a selected reference only. Full harmonised standards, biocompatibility testing and supporting documentation may be reviewed with qualified B2B partners where applicable.
Regulatory documentation for verified B2B counterparties
PAMITEX products are supplied within the applicable European regulatory framework. Public product pages provide essential compliance information for initial commercial evaluation.
Certificates, declarations, regulatory records and supporting documentation are not publicly distributed. Access may be granted only to verified professional counterparties where the requested documentation is relevant to a genuine commercial transaction, distribution agreement, private label project or regulatory due-diligence process.
Requests are reviewed individually. PAMITEX GROUP Kft. may require company verification, a confidentiality agreement, a confirmed commercial project, an order or an applicable documentation review fee before releasing restricted materials.
Submission of a request does not guarantee access to confidential documentation.
Request regulatory reviewThe information provided on this website is intended for B2B commercial evaluation only. It does not replace official product labelling, instructions for use, declarations of conformity, technical documentation or applicable regulatory obligations. Qualified partners may request official documentation directly from PAMITEX. Nothing on this website limits any documentation obligation imposed by applicable law, a competent authority or an existing written agreement.
Trademarks
PAMITEX · SILHOUETTE · SUPER SILHOUETTE · ENSITY
Trademarks of PAMITEX GROUP Kft.